POSTED 05/11/2023
Senior Quality Engineer
Location: Minneapolis, MN
Senior Quality Engineer – Direct Hire
Brooklyn Park, MN
Currently looking for a skilled individual to fill a Direct Hire Senior Quality Engineer opening with a company in Brooklyn Park, MN. Interested candidates should have 10 years of experience in medical device manufacturing, along with excellent communication, computer and time management skills.
Senior Quality Engineer Job Description:
- Provide quality engineering support to the project team to ensure design controls are followed & quality system principles are implemented & followed throughout the design process
- Identify & manage risk throughout the development process by ensuring a risk analysis for all products is completed using ISO 14971 & perform a FMEA when applicable
- Coordinate, review & approve process validation & associated protocols & reports to ensure they meet the intended purpose & ensure testing meets regulatory requirements & quality
- Ensure deliverable requirements are received, filed & maintained in the DHF/Technical File
- Ensure selected design components are qualified per internal documented requirements
- Ensure selected suppliers are approved per requirements
- Define & implement incoming & in-process inspection & final product test requirements
- Participate in internal & external quality audits
- Generate quality system documentation, review & approve deviations and/or engineering change orders & generate quality system documentation
- Participate in manufacturing transfer planning & implementation
- Ensure all finished goods meet established customer & company quality standards
- Design & develop new test methods & equipment
- Author protocols/procedures for testing, qualification & validation of product/processes
Senior Quality Engineer Job Requirement:
- Bachelors of Science or Arts Degree preferred or appropriate training
- Minimum of 10 years’ experience in medical device manufacturing/process development
- Experience in process design development and product development team environment
- ISO 13485 and FDA QSR requirements including design controls and risk management
- Implement, execute, and maintain quality system policies and procedures
- Define problems, collect data, establish facts, and draw valid conclusions
- Proficient in MS Office (Word, Excel, Access, and PowerPoint), internet and e-mail systems
- Accurately prioritize and execute with minimal direction
- Interpret/Understand drawing specifications, tolerances, procedures and sampling plans
- Use pin gauges, micrometers, calipers, pressure gauges, rules, and microscopes
- Knowledge of theory and principles of statistics and statistical process control
- Diverse knowledge of inspection and control methods, techniques, and documentation
The starting salary for the Senior Quality Engineer position is $110,000 annually DOE.